Non Surgical Closure of Patent Foramen Ovale(PFO)

Patent Foramen Ovale (PFO) is a congenital heart defect, characterized by incomplete closure of the foramen ovale, an opening in the septum (wall) between the right and left upper chambers of the heart. The foramen ovale allows blood to bypass the fetal lungs. Normally the opening closes during infancy, but if it does not close it is called a patent foramen ovale. This type of defect generally works like a flap valve, opening up when the pressure inside the chest increases by coughing, sneezing or straining during a bowel movement. This pressure can open the defect, allowing blood to pass from the right atrium to the left atrium. If there is a clot in the blood, it can cross over to the left atria and can lodge in the brain causing a stroke or in the heart causing a heart attack.

A patent foramen ovale usually causes no signs or symptoms and is not treated unless the child or adult has symptoms of transient ischemic attack (TIA) or stroke. A PFO can be detected with an echocardiography, a chest X-ray and Cardiac MRI scan. Blood thinning medications may be used for a patient with a PFO who have had a stroke to reduce the risk of blood clot formation. Nonsurgical (catheter based) closure of the hole is an alternative for individuals unable to take blood-thinning medications or those who have a second stroke while on medications.

Procedure

The non-surgical closure of Patent Foramen Ovale (PFO) involves the following steps:

  • A small puncture is made in your groin.
  • A thin, hallow, flexible tube (catheter) is inserted into a blood vessel in the groin and guided to the heart.
  • A balloon is placed and inflated across the opening to determine the size and location of the hole.
  • A PFO closure device is delivered to the heart through the catheter.
  • The device is positioned to close the hole with the imaging assistance of an echo transducer.
  • The device is then released from the catheter so that it covers each side of the defect and completely seals it closed.
  • The catheter is then removed and the closure device stays in place permanently in your heart.

There are different types of devices available for non-surgical closure of PFO, such as AMPLATZER PFO occluder, STARflex septal repair implant and GORE HELEX Septal Occluder. Patients are advised to take their prescribed blood thinning medication usually for 6 months or longer to prevent blood clot formation.

Instructions for Patients with Patent Foramen Ovale (PFO)

Patent Foramen Ovale (PFO) is a common condition where a flap or a tunnel-like "communication" (hole) exists between the two upper chambers (atria) of the heart. It often causes no problems. However, in a small subset of patients it may allow clots to form or to pass from the right side of the heart to the left circulation, which can cause TIA, stroke, and even severe migraines. The diagnosis of this condition is made by the collaboration of your neurologist and your cardiologist. A TEE with bubble study is needed to make the diagnosis of PFO. It can be treated medically, surgically, or with a non-surgical closure technique. Your physicians may determine that you are a candidate for a non-surgical technique of closure of this defect utilizing a device delivered from the femoral vein approach. Further details of this device are available at the NMT Medical website.

Evaluation, Education, and Preparation

You are seen in the HeartPlace offices. Please arrange a consultation by calling the office of a Heartplace physician who performs this procedure.

Review of your medical records is required. You can greatly facilitate your evaluation process by working with our office to obtain records and copies of TEE tape or CD.

Blood testing for excessive clot formation (hypercoaguable condition) is required. Reporting a family history of this condition is critical.

You are treated with aspirin and Plavix (antiplatelets, blood thinner) for six months after the procedure. It is important to report all drug allergies and intolerances before the procedure.

Our office sends you forms to fill out before your procedure.

We discuss the specific risks, benefits, and alternatives to the procedure.

Procedure

The procedure is performed in the cardiac cath lab at the Baylor Jack and Jane Hamilton Heart and Vascular Hospital. Intravenous sedation and antibiotics are administered before the procedure. An intracardiac echocardiogram (ICE) or transesophageal echocardiogram (TEE) is performed during the procedure. Through a catheter placed in the groin area, the PFO is crossed with a wire and the size is measured with a special balloon. Thereafter, the appropriate device is selected to treat the PFO. Immediately after the procedure, the femoral sheath (tube) is removed, and five to ten minutes of pressure is used to stop the bleeding. After the sedation wears off (four to eight hours), you are allowed to eat and to walk in the hallways. You will probably be discharged from the hospital the same evening or the next morning.

Risks

This procedure is effective, but it has associated risks that include stroke, TIA, infection of the device, the need for surgical removal of the device, bleeding requiring a transfusion, vascular damage, cardiac puncture requiring emergency surgery, severe cardiac rhythm problems, contrast allergy, kidney failure (temporary or permanent), esophageal damage caused by TEE, reaction to medication, bleeding, and intolerance to blood thinners. Other patient-specific risks may also apply. The long-term effects of this device (beyond seven to ten years) are unknown. Adherence to follow-up and compliance with medications are critical.

Follow Up

  • Office visit and echocardiogram at one and six months.
  • Annual cardiology office visit.
  • Maintain follow-up with neurologist and primary care physician.
  • Aspirin (81 or 325 mg) and Plavix (75 mg) tablet daily for six months. (You should take Plavix with meals.) Follow all precautions regarding this potent blood-thinning combination. Report any evidence of bleeding complications to your physicians.
  • You will receive subacute bacterial endocarditis prophylaxis as determined by the American Heart Association guidelines. You should receive antibiotics for dental and certain other procedures for six months after the procedure. After six months, the device is covered by healthy tissue and no further endocarditis prophylaxis is necessary.
  • If you develop symptoms of recurrent stroke, TIA, shortness of breath, irregular rhythm or other cardiac symptoms, fever, chills, or groin problems, please contact your physician or our office.

These are general guidelines. Other specific instructions may apply to your condition. If you have any doubts, you should contact the implanting physician.

Service Providers

Baylor All Saints

Baylor Heart Hospital

HeartPlace Plano